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Pediatric Apple Watch Study

Leveraging Wearable Technologies for Arrhythmia Detection in Children - The PAW (Pediatric Apple Watch) Study

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06053372
Acronym
PAWS
Enrollment
100
Registered
2023-09-25
Start date
2024-08-16
Completion date
2026-03-31
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia in Children

Brief summary

Specific Aim #1 - To determine the accuracy of Apple Watch ECG tracings heart rate in children. Specific Aim #2 - To determine if extended monitoring with the Apple Watch can identify arrhythmia events that were not detected by short term clinical monitoring.

Interventions

Wearable monitor for heart rate and arrhythmia detection

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 21 Years
Healthy volunteers
No

Inclusion criteria

* All pediatric patients age 6 - 21 years undergoing clinically indicated arrhythmia monitoring * Patients with developmental ability (as determined by patient and parents) to safely wear the Apple Watch and utilize the patient activated trigger buttons on both the clinical monitor and the Apple Watch.

Exclusion criteria

* Age \< 6 years. Those under 6 many not be able to safely use the watch and have the developmental ability (as gauged by clinician and parents) to utilize the trigger features on the watch and cardiac rhythm monitor. * Inability to effectively utilize the triggered features of the monitor or watch * Patients unable to utilize the Apple Watch.

Design outcomes

Primary

MeasureTime frameDescription
Heart rate correlationUp to 2 weeksComparison of heart rate (bpm) between the Apple Watch and standard clinical rhythm monitor
Arrhythmia correlationUp to 6 monthsComparison of the number of clinically significant arrhythmia events between the Apple Watch and standard clinical rhythm monitor. Clinically significant arrhythmia events include supraventricular arrhythmias, ventricular arrhythmias, sinus pauses, and conduction abnormalities/heart block

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026